Clinical Study of CMR to Evaluate the Effect of Ivabradine on the Improvement of Left Ventricular Remodeling in STEMI Patients After Primary PCI

Cardiovascular Diseases Clinical Trial

Official title:

Clinical Study of CMR to Evaluate the Effect of Ivabradine on the Improvement of Left Ventricular Remodeling in STEMI Patients After Primary PCI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05348057
• Other study ID #: qg-2021-12-01
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: April 2022
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aim to investigate the effect of ivabradine on reducing infarct size and improving left ventricular remodeling after in patients undergoing primary PCI for ST-elevation myocardial infarction through myocardial enhanced MRI.

Description:

Investigators will enroll 240 patients with STEMI who were admitted to the Chinese PLA General Hospital between October 2020 and October 2021，the investigators randomly assign eligible patients in a 1:1 ratio to either ivabradine or oral placebo befor primary PCI. The treatment was initiated after primary PCI with ivabradine orally for 6 months. Primary end point of the study was the area of infarct size measured by cardiac magnetic resonance (CMR). Cardiovascular events concluding stroke, repeat revascularization, rehospitalization for acute heart failure, nonfatal myocardial infarction, and all cause death. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• STEMI patients: typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in =2 contiguous electrocardiographic leads, and elevated blood levels of troponin T

• patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions

Exclusion Criteria:

• had once treated by ivabradine

• history of myocardial infarction

• mechanical complications

• Unable to perform myocardial MRI

• liver and kidney failure

• malignant tumor

• unconscious

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Ventricular Remodeling

Intervention

Drug:
• Ivabradine
The starting dose is 5 mg twice a day. Adjust the dose according to the actual situation

Locations

Country	Name	City	State
China	Chinese People's Liberation Army General Hospital	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Qian geng

Country where clinical trial is conducted

China, 

References & Publications (10)

Borer JS, Böhm M, Ford I, Komajda M, Tavazzi L, Sendon JL, Alings M, Lopez-de-Sa E, Swedberg K; SHIFT Investigators. Effect of ivabradine on recurrent hospitalization for worsening heart failure in patients with chronic systolic heart failure: the SHIFT Study. Eur Heart J. 2012 Nov;33(22):2813-20. doi: 10.1093/eurheartj/ehs259. Epub 2012 Aug 27. — View Citation

Borer JS, Böhm M, Ford I, Robertson M, Komajda M, Tavazzi L, Swedberg K; SHIFT Investigators. Efficacy and safety of ivabradine in patients with severe chronic systolic heart failure (from the SHIFT study). Am J Cardiol. 2014 Feb 1;113(3):497-503. doi: 10.1016/j.amjcard.2013.10.033. Epub 2013 Nov 9. — View Citation

De Ferrari GM, Mazzuero A, Agnesina L, Bertoletti A, Lettino M, Campana C, Schwartz PJ, Tavazzi L. Favourable effects of heart rate reduction with intravenous administration of ivabradine in patients with advanced heart failure. Eur J Heart Fail. 2008 Jun;10(6):550-5. doi: 10.1016/j.ejheart.2008.04.005. Epub 2008 May 16. — View Citation

Ekman I, Chassany O, Komajda M, Böhm M, Borer JS, Ford I, Tavazzi L, Swedberg K. Heart rate reduction with ivabradine and health related quality of life in patients with chronic heart failure: results from the SHIFT study. Eur Heart J. 2011 Oct;32(19):2395-404. doi: 10.1093/eurheartj/ehr343. Epub 2011 Aug 29. — View Citation

Hidalgo FJ, Anguita M, Castillo JC, Rodríguez S, Pardo L, Durán E, Sánchez JJ, Ferreiro C, Pan M, Mesa D, Delgado M, Ruiz M. Effect of early treatment with ivabradine combined with beta-blockers versus beta-blockers alone in patients hospitalised with heart failure and reduced left ventricular ejection fraction (ETHIC-AHF): A randomised study. Int J Cardiol. 2016 Aug 15;217:7-11. doi: 10.1016/j.ijcard.2016.04.136. Epub 2016 Apr 19. — View Citation

Joannides R, Moore N, Iacob M, Compagnon P, Lerebours G, Menard JF, Thuillez C. Comparative effects of ivabradine, a selective heart rate-lowering agent, and propranolol on systemic and cardiac haemodynamics at rest and during exercise. Br J Clin Pharmacol. 2006 Feb;61(2):127-37. — View Citation

Logeart D, Gueffet JP, Rouzet F, Pousset F, Chavelas C, Solal AC, Jondeau G. Heart rate per se impacts cardiac function in patients with systolic heart failure and pacing: a pilot study. Eur J Heart Fail. 2009 Jan;11(1):53-7. doi: 10.1093/eurjhf/hfn016. — View Citation

Sisakian H, Sargsyan T, Khachatryan A. Effect of selective heart rate reduction through sinus node I_f current inhibition on severely impaired left ventricular diastolic dysfunction in patients with chronic heart failure. Acta Cardiol. 2016 Jun;71(3):317-22. doi: 10.2143/AC.71.3.3152092. — View Citation

Swedberg K, Komajda M, Böhm M, Borer J, Robertson M, Tavazzi L, Ford I; SHIFT Investigators. Effects on outcomes of heart rate reduction by ivabradine in patients with congestive heart failure: is there an influence of beta-blocker dose?: findings from the SHIFT (Systolic Heart failure treatment with the I(f) inhibitor ivabradine Trial) study. J Am Coll Cardiol. 2012 May 29;59(22):1938-45. doi: 10.1016/j.jacc.2012.01.020. — View Citation

Tardif JC, O'Meara E, Komajda M, Böhm M, Borer JS, Ford I, Tavazzi L, Swedberg K; SHIFT Investigators. Effects of selective heart rate reduction with ivabradine on left ventricular remodelling and function: results from the SHIFT echocardiography substudy. Eur Heart J. 2011 Oct;32(20):2507-15. doi: 10.1093/eurheartj/ehr311. Epub 2011 Aug 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial infarct size according to MR delayed enhancement scan	Two experienced MRI cardiologists analyzed the delayed enhancement image enhancement area of MRI to obtain the area of myocardial infarction through the Segment v1.9 post-processing software	7 days after PCI
Primary	main cardiovascular events	Acute heart failure, recurrence of myocardial infarction, death from all causes, stroke, cardiac death, recurrent myocardial infarction, recurrent target vascular revascularization, re-admission because of angina pectoris or heart failure	follow up in 6 months
Secondary	change of the LVEF	left ventricular ejection fraction (LVEF)	follow up in 6 months